Regulatory Affairs Manager

Vor 5 Tagen

Zürich, Schweiz Takeda Pharmaceutical Vollzeit

**People First** - At Takeda we are dedicated to improving the health and well-being of all people and bringing them the hope of a brighter future. It is our passion that transforms every job into meaningful action. **Our people are the heart of Takeda.** Our team is growing and for this we need bright minds with creativity and flexibility - what talent do you have?

**We are currently hiring for a Regulatory Affairs Manager (all genders) on a permanent contract for our Swiss local office in Glattpark (Opfikon).**:
**Your tasks in detail**:

- Manage **MA lifecycle maintenance** for a defined product portfolio, including local impact assessments of global changes, preparation, and filing of renewals, variations (CMC and non-CMC), labeling updates, PSUR/PBRERs etc. to ensure national registrations and comply with Swiss local requirements.
- Applications for new **Marketing Authorization and line-/ indication extensions** in collaboration with global and local functions as eCTD Format to Swissmedic
- Ensure **compliance of labelling** (and mock-ups) with the CCDSs and manage communication to internal and external stakeholders as applicable to ensure timely implementation
- Contact for the assigned products towards Swissmedic and respond within required Deadlines to Swiss Authorities
- Represent Regulatory Affairs for the defined product portfolio in internal cross-functional meetings and projects
- Support LOC QA Switzerland for product releases
- Maintain **global and local regulatory databases** and systems to ensure accurate records of regulatory activities and documentation
- Review **promotional and educational materials** for the assigned product portfolio
- Contribute to Regulatory Intelligence and assess impact on local business and products
- Striving for a performance-based culture and deliver operational excellence working in a cross-functional environment within R&D and the Commercial business based on the company’s values of Patient, Trust, Reputation and Business.

**Your profile**:

- University degree in Pharmacy or other scientific studies
- Minimum 2-5 years’ experience in Regulatory Affairs within a pharmaceutical company, CRO, similar organization in Switzerland or Swissmedic.
- Advanced knowledge of applicable Swiss laws, regulations, and codices for pharmaceutical industry in Switzerland
- Business fluency in German and English (speaking and writing)
- Cross-functional mindset: Strong communicator with the ability to engage both external and internal customers
- Growth mindset: Strong ability to assimilate information (technical, regulatory, scientific) and discuss the relevance and impact on the assigned product portfolio and/or Marketing Authorization Applications
- Readiness to adapt to changing situations and drive necessary adaptations

**Desirable Additional Skills**:

- Additional national language is a plus (French / Italian)

**Empowering our people to shine**

**Diversity, Equity and Inclusion**

**Locations**: Zurich, Switzerland

**Worker Type**: Employee

**Worker Sub-Type**: Regular

**Time Type**: 80-100%

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